On March 7, 2024 BioCentriq, Inc., a global cell therapy Contract Development and Manufacturing Organization (CDMO), reported a significant enhancement to its partnership with Pluristyx Inc., an early stage, privately held biotechnology company specializing in Induced Pluripotent Stem Cell (iPSC) products (Press release, panCELLa, MAR 7, 2024, View Source [SID1234640933]). Through BioCentriq’s process development services, their strategic collaboration now includes seamless access to Pluristyx’s proprietary iPSC lines to help lower the barrier to entry, provide a swift translation to clinic, and ensure the best path to commercialization for the next generation of iPSC-derived treatments.

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Pluristyx’s unique clinical-grade iPSC lines, derived from regulatory-compliant starting material and reprogrammed using proprietary mRNA technology, represent a breakthrough in cell therapy development, providing stability, scalability, and customization potential for enhanced therapeutic outcomes. Building upon the existing research agreement, BioCentriq will extend its capabilities by incorporating Pluristyx’s iPSC lines into its cell therapy development and manufacturing processes. This expansion aims to facilitate an integration of Pluristyx’s proprietary iPSC lines, further optimizing the activation, expansion rate, and manufacturability of iPSC-derived NK cells.

"Expanding our collaboration with Pluristyx to include access to iPSC lines is a significant leap forward for BioCentriq and our clients," said Alex Klarer, Vice President of Business Strategy and Innovation at BioCentriq. "This capability enhancement underscores BioCentriq’s commitment to providing our clients with state-of-the-art resources to accelerate the development and manufacture of innovative cell-based therapies including next-generation iPSC-derived treatments."

"Pluristyx is excited to expand our relationship with BioCentriq to provide streamlined access to our research- and clinical-grade iPSC lines and accelerate the development of next generation therapeutics," states Dr Benjamin Fryer, Chief Executive Officer and Co-Founder of Pluristyx. "Our best-in-class iPSC lines offer a simplified path to commercialization, and are made available pre-edited with our exclusive FailSafe and iACT Stealth Cells platform technologies to provide unparalleled safety and cloaking capabilities to overcome the inherent challenges of iPSC-derived therapies."

On March 7, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a business update and provided fourth quarter and full year 2023 financial results (Press release, Oncternal Therapeutics, MAR 7, 2024, View Source [SID1234640932]).

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"We are encouraged by the progress in our clinical programs and their potential to address significant unmet needs in advanced prostate cancer and aggressive B-cell malignancies. Our Phase 1 study of ONCT-534 in patients with R/R mCRPC is progressing through the initial dose escalation portion of the study according to plan and we look forward to an initial clinical readout in the second quarter of this year that will include response readouts from patients dosed at potentially therapeutic levels. We continue to believe that the novel mechanism of action of ONCT-534 and the wealth of preclinical data we generated underpins its potential to address the needs of prostate cancer patients who progress after treatment with approved AR pathway inhibitors," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Our ROR1 CAR T program showed encouraging initial response results and we believe that the protocol amendments will further ensure patient safety as we investigate the optimal dose of ONCT-808 for patients with relapsed or refractory aggressive B cell lymphoma, including patients who have relapsed after CD19 CAR T treatment."

Recent Highlights

In January 2024, we announced that two patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled into the third dosing cohort (160 mg daily) in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, our novel dual-action androgen receptor inhibitor (DAARI). The third cohort is now fully enrolled.
In December 2023, we updated the status of our dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating our ROR1-targeting autologous CAR T cell therapy ONCT-808 for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment.
Encouraging response signal at the initial dose of 1×106 CAR T cells per kg, with two of the three patients achieving complete metabolic response (CMR) and the third achieving a partial response (PR) by FDG PET-CT.
Common adverse events in the initial dosing cohort included decreased blood counts, pneumonia and Grade 1-2 cytokine release syndrome (CRS) as of a 4 December 2023 data cutoff.
The first patient treated at the second dose level of 3×106 CAR T cells per kg, an 80-year-old with bulky disease who had received four previous lines of therapy including CD19 CAR T, experienced a Grade 5 (fatal) serious adverse event consistent with CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report.
In alignment with the U.S. Food and Drug Administration, the company decided to implement protocol changes that include modified eligibility criteria and testing lower doses for future patients in the study.
In January 2024, we announced a 1-for-20 reverse stock split of our common stock and regained compliance with Nasdaq’s minimum bid price requirement.
Expected Upcoming Milestones

ONCT-534, our dual-action androgen receptor inhibitor
Initial clinical data update in the second quarter of 2024
Additional clinical data readouts in the fourth quarter of 2024
ONCT-808, our autologous ROR1-targeted CAR T cell therapy
Clinical data update in mid-2024
Additional clinical data readouts in the fourth quarter of 2024

On March 7, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported recent operational highlights and financial results for the fourth quarter and year ended December 31, 2023 (Press release, Oncolytics Biotech, MAR 7, 2024, View Source [SID1234640931]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Positive 2023 data further de-risked pelareorep and re-defined Oncolytics as a late-stage cancer company. Data from the randomized BRACELET-1 breast cancer trial in HR+/HER2- metastatic patients, reported in June using a March 3, 2023 cut-off date, nearly tripled response rates in the test arm compared to the control arm. Additionally, median progression-free survival was 50% higher in the test arm, and the hazard ratio was 0.29. In the coming months, we expect to report overall survival results from the BRACELET-1 study and define a registrational path that will focus on patients with metastatic HR+/HER2- disease and utilize a pelareorep/paclitaxel combination. Productive, ongoing discussions with our clinical collaborators and potential strategic partners have sharpened and enriched our thinking on the design of this study," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

"Our gastrointestinal-focused GOBLET Phase 1/2 study showed that pelareorep combinations provided clinically impactful improvements in objective response rates compared to historical controls, especially in the pancreatic and anal cancer cohorts, and with no toxicity concerns. With these results in hand, we have expanded enrollment in the anal cancer cohort, and, in pancreatic cancer, we intend to initiate an adaptive trial in first-line patients this year. This registration-enabled study will be a landmark achievement for Oncolytics and evaluate the GOBLET pancreatic cohort treatment regimen that was granted Fast Track designation by the FDA. Additionally, the planned PanCAN-supported trial utilizing a modified FOLFIRINOX (mFOLFIRINOX)-pelareorep combination could expand our pancreatic cancer program to include both of the most widely used treatment backbones, which may result in broad adoption of pelareorep as a therapeutic solution in this indication.

New translational data in breast and pancreatic cancer reported in the fourth quarter continued to highlight pelareorep’s role in stimulating tumor-directed immune responses and shaping the tumor microenvironment, affirming its immunotherapeutic mechanism of action (MOA). These studies also point to the potential use of tumor-infiltrating lymphocytes, or TILs, as a clinical biomarker for future studies and patient care based on a positive association with tumor responses. We are optimistic about the potential for pelareorep to provide improved outcomes for cancer patients and look forward to updating investors and our key stakeholders on our registrational readiness and progress as the year unfolds," concluded Dr. Coffey.

Fourth Quarter and Subsequent Highlights

Expansion of enrollment in the GOBLET anal carcinoma cohort. Cohort 4 of the GOBLET study evaluates pelareorep in combination with atezolizumab (Tecentriq) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The cohort was expanded (link to the PR) based on positive preliminary data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC), showing that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability (link to the PR, link to the poster). These data represent a meaningful contrast to recent clinical trial results, which showed that second-line or later anal carcinoma patients treated with checkpoint inhibitor monotherapy experienced response rates of 10-14%1-3. With a modest expansion of fewer than 20 patients, there could be a sufficient efficacy signal to move to a registrational study.

Additional positive data from the gastrointestinal cancer Phase 1/2 GOBLET study. Pancreatic and colorectal cancer data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. Additional data were reported from Pancreatic Ductal Adenocarcinoma (PDAC) patients in cohort 1, including median progression-free survival and interim median overall survival rates that exceed historical control results (link to the PR, link to the poster). Third-line metastatic colorectal cancer patients receiving pelareorep, atezolizumab, and trifluridine/tipiracil (Cohort 3) recorded a 40% disease control rate and met the pre-specified success criteria according to the Simon two-stage methodology (link to the PR, link to the poster). All three GOBLET study cohorts that have completed Stage 1 met the pre-specified success criteria.

Filed amendment to initiate Phase 1/2 pancreatic cancer study with support from PanCAN. Cohort 5 of the GOBLET study will evaluate pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed PDAC patients. Having filed the amendment to the GOBLET study, the Paul Ehrlich Institute (Germany’s regulatory body) must approve this change before patient enrollment in this cohort can begin (link to the PR). The study is being supported by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

Positive translational data from further analysis of the AWARE-1 breast cancer and GOBLET studies. AWARE-1 data presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS) 2023 underscored pelareorep’s MOA as an immunotherapeutic agent. These data showed the expansion of T cell populations in both the tumor and blood in patients treated with pelareorep. Importantly, translational data from pancreatic cancer patients reported at ESMO (Free ESMO Whitepaper) showed a correlation between tumor response and the expansion of TIL clones in the blood. This expansion of tumor resident T cells demonstrates that pelareorep treatment can increase the population of presumed tumor-reactive inflammatory cells and could become an informative biomarker of clinical outcomes to be used in future clinical studies and guide patient care.

Addition of new Director, Pat Andrews. Pat Andrews joined the Oncolytics Board of Directors and brings experience navigating registrational trials in oncology and completing significant business development agreements. Her addition expands the strategic expertise of the Board, helping to accelerate the company’s registrational plans and transformational mindset as a late-stage oncology company.

Financial Highlights

•As of December 31, 2023, the Company reported $34.9 million in cash and cash equivalents, with a projected cash runway for at least 12 months.

•Net cash used in operating activities for the twelve months ended December 31, 2023 was $28.4 million, compared to $23.4 million for the twelve months ended December 31, 2022. The change reflected higher net operating activities.

•General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022. The increase was primarily due to higher investor relations activities and changes in personnel costs.

•Research and development expenses for the fourth quarter of 2023 were $4.7 million, compared to $4.8 million for the fourth quarter of 2022. The decrease was primarily due to lower GOBLET and BRACELET-1 study costs, as well as reduced clinical and safety data management. The decrease was partly offset by higher manufacturing expenses related to the preparation and start of a production run.

•The net loss for the fourth quarter of 2023 was $3.9 million, compared to a net loss of $8.6 million for the fourth quarter of 2022. The basic and diluted loss per share was $0.05 in the fourth

quarter of 2023, compared to a basic and diluted loss per share of $0.14 in the fourth quarter of 2022. The net loss for the fourth quarter of 2023 included a $4.8 million gain mainly related to the change in fair value of the warrants issued as part of our 2023 public offering.

Anticipated Milestones

•H1 2024: Guidance on the registration path for HR+/HER2- mBC (metastatic breast cancer)
•H1 2024: Initiation of the Phase 1/2 PDAC trial incorporating pelareorep/mFOLFIRINOX +/- atezolizumab and supported by PanCAN
•2024: Initiation of the adaptive registration-enabling trial for pelareorep in first-line metastatic PDAC
•H2 2024: Overall survival results from the BRACELET-1 trial

Webcast and Conference Call

Management will host a conference call for analysts and investors at 4:30 p.m. ET today, March 7, 2024. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International), and if needed, provide Conference ID: 6244-5815. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 445-815#.

On March 7, 2024 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its full year 2023 financial results for the period ended December 31, 2023 (Press release, Merrimack, MAR 7, 2024, View Source [SID1234640929]).

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"As Ipsen reported in February, the U.S. Food and Drug Administration has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) as a first-line treatment for people living with metastatic pancreatic ductal adenocarcinoma (mPDAC)" said Gary Crocker, CEO and Chairman of Merrimack’s Board of Directors. "This approval triggers a $225 million payment which is due from Ipsen to Merrimack before the end of March. We expect to hold a special meeting of stockholders to approve a Plan of Dissolution and a liquidating dividend payable to stockholders. We currently anticipate the initial liquidating dividend to be in the range of between approximately $14.65 and $15.35 per share."

Full Year 2023 Financial Results

Merrimack reported net loss of $1.2 million for the year ended December 31, 2023, or $0.08 per basic share, compared to a net loss of $1.5 million, or $0.11 per basic share, for the same period in 2022.

Merrimack reported a gain on sale of assets for the year ended December 31, 2023, of $0.1 million compared to $0.4 million for the same period in 2022.

General and administrative expenses for the year ended December 31, 2023 were $2.2 million, compared to $2.2 million for the same period in 2022.

As of December 31, 2023, Merrimack had cash, cash equivalents and short-term investments of $18.9 million, compared to $19.4 million as of December 31, 2022.

As of December 31, 2023, Merrimack had 14.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments and Planned Dissolution

On February 13, 2024, we announced that Ipsen S.A. announced it had received approval from the U.S. Food and Drug Administration, or FDA, to market ONIVYDE as a first-line treatment of metastatic adenocarcinoma on the pancreas. As a result of this approval by the FDA, we are entitled to receive a $225 million milestone payment from Ipsen, which is expected to be received by the end of March 2024.

Merrimack’s Board of Directors has evaluated the likelihood of receiving additional milestone payments under the Ipsen Agreement and from the 2019 Agreement with Elevation Oncology and has concluded that it is unlikely that any additional milestone payments from either agreement will become payable. The Plan of Dissolution will include establishment of a liquidating trust for the benefit of stockholders in the unlikely event that Merrimack might receive any future milestone payments from Ipsen or Elevation Technology.

On March 7, 2024 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and announced financial results for the year ended December 31, 2023 (Press release, MacroGenics, MAR 7, 2024, View Source [SID1234640928]).

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"We expect that 2024 will be an important year for MacroGenics, with multiple pipeline advancements anticipated," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Late last year, we completed enrollment of 177 patients in the TAMARACK Phase 2 study of vobra duo, which was ahead of schedule. We plan to present the initial TAMARACK clinical data in the second quarter of this year. Later in the year, we expect to share updated clinical data from the trial. In addition, we continue to enroll the LORIKEET Phase 2 study of lorigerlimab in mCRPC and expect to start enrolling patients in the dose expansion portion of the combination study of vobra duo and lorigerlimab. Finally, we are excited about the potential of our topoisomerase I inhibitor-based ADCs, including MGC026, for which we recently began a Phase 1 study, and MGC028, for which we anticipate submitting an IND by year end."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation.
MacroGenics completed enrollment of the TAMARACK Phase 2 study of vobra duo in November 2023. A total of 177 patients have been dosed in the study, exceeding the study design goal of 100 participants. TAMARACK is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W).

In late January 2024, the TAMARACK independent data safety monitoring committee (IDSMC) recommended continuing the study. Also, in early February, MacroGenics submitted an abstract to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) that included the safety data reviewed by the IDSMC, based on a January 2024 data cut-off. The Company anticipates presenting updated safety and preliminary efficacy data at ASCO (Free ASCO Whitepaper).
MacroGenics intends to expand the TAMARACK study of vobra duo by enrolling patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and anal cancer. The Company expects to initiate dosing in these additional cohorts in mid-2024.
MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination in mCRPC and at least one additional indication in 2024.
Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of radiographic progression-free survival (rPFS). The Company anticipates providing a study update in the second half of 2024.
MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
MGC026 is a clinical ADC directed against B7-H3, incorporating a novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. The Company plans to present MGC026 preclinical data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024. MacroGenics recently initiated a Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors.
MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease domain 9) is a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment. MacroGenics plans to present preclinical data for MGC028 at the upcoming AACR (Free AACR Whitepaper) Annual Meeting in April and currently anticipates submitting an investigational new drug (IND) application for MGC028 by the end of 2024.

MGC028 is the second ADAM9-targeted ADC that MacroGenics has pursued. The first was IMGC936, a molecule with a maytansinoid payload that was advanced under a co-development arrangement with ImmunoGen, Inc. (ImmunoGen, now part of AbbVie). Under the 50/50 collaboration, ImmunoGen led clinical development and completed initial Phase 1 dose escalation and dose expansion studies. Neither MacroGenics nor AbbVie intends to further pursue development of IMGC936 as the molecule did not achieve pre-established clinical safety and efficacy benchmarks. The Company believes ADAM9 remains a promising target for delivery of an alternative cytotoxic payload.
Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. MacroGenics’ academic collaborators have initiated the HEAT study, an investigator-sponsored, randomized Phase 2 clinical trial. This study will evaluate the activity of neoadjuvant enoblituzumab given prior to radical prostatectomy in up to 219 men with high-risk localized prostate cancer.
2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of December 31, 2023, was $229.8 million, compared to $154.3 million as of December 31, 2022.
Revenue: Total revenue was $58.7 million for the year ended December 31, 2023, compared to total revenue of $151.9 million for the year ended December 31, 2022. The decrease was primarily due to a decrease in revenue from collaborative and other agreements.
R&D Expenses: Research and development expenses were $166.6 million for the year ended December 31, 2023, compared to $207.0 million for the year ended December 31, 2022. The decrease was primarily due to decreased manufacturing-related costs for vobra duo, decreased development and clinical trial costs related to margetuximab, and decreased costs related to discontinued studies, partially offset by increased expenses related to MGC026 and MGC028 development.
SG&A Expenses: Selling, general and administrative expenses were $52.2 million for the year ended December 31, 2023, compared to $58.9 million for the year ended December 31, 2022. The decrease was primarily related to decreased selling costs for MARGENZA.
Other Income: During the year ended December 31, 2023, MacroGenics received $100.0 million proceeds from the sale of its single-digit royalty interest on global net sales of TZIELD to DRI Healthcare Acquisitions LP. In addition, the Company received a $50.0 million milestone payment from Sanofi S.A. related to the achievement of a primary endpoint in a TZIELD clinical study. Under GAAP guidelines and pursuant to Financial Accounting Standards Board’s Accounting Standards Codification 470, this combined $150.0 million was included in Other Income as a "Gain on royalty monetization arrangement" in 2023.
Net Loss: Net loss was $9.1 million for the year ended December 31, 2023, compared to net loss of $119.8 million for the year ended December 31, 2022.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2023 were 62,070,627.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $229.8 million as of December 31, 2023, in addition to projected and anticipated future payments from partners and product revenues should extend its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies.
Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.